UMIN-CTR Clinical Trial

Basic information
Public title	SNP analysis of brexpiprazole-treated Japanese schizophrenia patients.
Acronym	Genomics analysis-schizophrenia
Scientific Title	SNP analysis of brexpiprazole-treated Japanese schizophrenia patients.
Scientific Title:Acronym	Genomics analysis-schizophrenia
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To explore factors associated with drug response in Japanese patients with schizophrenia based on information in clinical evaluation index and genetic information collected from those patients who have attended a clinical trial(Clinical Trials. gov, NCT01451164, #331-10-002).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Factors which influence antipsychotics responses will be explored.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	-Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria -Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent -Patients who are experiencing acute exacerbation of psychotic symptoms
Key exclusion criteria	-Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product -Patients presenting a first episode of schizophrenia based on the clinical judgement of the investigator -Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis I criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
Target sample size	280

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroko Komatsu
Organization	Otsuka Pharmaceutical, Co., Ltd
Division name	New Drug Research Division
Zip code
Address	Kagasuno 463-10, kawauchi-cho, Tokushima-shi, Tokushima 771-0192
TEL	088-665-2126
Email	Komatsu.Hiroko@otsuka.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroko Komatsu
Organization	Otsuka Pharmaceutical, Co., Ltd
Division name	New Drug Research Division
Zip code
Address	Kagasuno 463-10, kawauchi-cho, Tokushima-shi, Tokushima 771-0192
TEL	088-665-2126
Homepage URL
Email	Komatsu.Hiroko@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 05 Day
Date of IRB	2017 Year 03 Month 14 Day
Anticipated trial start date	2018 Year 02 Month 19 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	Exploration of factors associated with drug response in patients with schizophrenia based on information in clinical evaluation index and genetic information collected from those patients who have attended a clinical trial for Brexpiprazole.

Management information
Registered date	2018 Year 02 Month 22 Day
Last modified on	2021 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035871